Price deal sees NICE back Imbruvica for one indication but not another

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Imbruvica (ibrutinib), within its marketing authorization, for use on the Cancer Drugs Fund (CDF) as an option for treating Waldenström’s macroglobulinemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed.

In what is a U-turn by the medicines cost-effectiveness watchdog, today’s positive final appraisal determination (FAD) means patients in England can now access ibrutinib via the CDF for the first time, according to the drug’s maker, Janssen, a unit of US healthcare giant Johnson & Johnson (NSE: JNJ).

The positive recommendation from NICE was based on clinical evidence from a Phase II single-arm, open-label trial in the US (PCYC-1118E). However, the NICE concluded that further collection of outcomes data would be needed before the treatment was recommended for routine use on the National Health Service (NHS).